# K141452: Leforte Neuro System Bone Plate and Screw

- Pathway: 510(k) (Special)
- Applicant: Jeil Medical Corporation
- Decided: Jul 2, 2014 after 30 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953806 (1996). 8 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112812: Leforte Neuro System Bone Plate, Jeil Medical Corporation (2012)

## Most influential descendants
- K210099: Meticuly Patient-Specific Titanium Mesh Implant (2021), 2 descendants of its own
- K252251: Easymade-TI (2026), 0 descendants of its own
- K252958: METICULY Patient-specific titanium mesh implant (2026), 0 descendants of its own
- K170368: Sterile NS System (2017), 0 descendants of its own

## Indications for use
This device is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

Source page: https://510kreport.com/device/K141452
Methodology: https://510kreport.com/methodology